FDA 510(k) Application Details - K102815

Device Classification Name	More FDA Info for this Device
510(K) Number	K102815
Device Name	SURELIFT PROLAPSE SYSTEM
Applicant	NEOMEDIC INTERNATIONAL 7307 GLOUCHESTER DRIVE EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2010
Decision Date	07/07/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review